Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

Active, not recruiting

• Conditions: Total Knee Arthroplasty

• Registration Number: NCT03687593
• Lead Sponsor: Smith & Nephew, Inc.

Brief Summary

The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-26
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-27
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2027-10-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. Subject received primary TKA with the Legion™ CR Femoral Implant (either Oxinium or CoCr) with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, degenerative arthritis, or rheumatoid arthritis).
2. Subject received primary TKA between 24 and 66 months prior to the time of consent.
3. Subject agrees to consent and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form.
4. Subject must be available through ten (10) years postoperative follow-up.

Exclusion Criteria

1. Subject had Body Mass Index (BMI) > 40 at time of surgery.
2. Subject received the Legion™ CR Femoral Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert as a revision surgery.
3. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
4. Subject has a known allergy to one or more of its components of the study device.
5. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
6. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
7. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant survival 10 years postoperatively	10 years post-op

Trial Locations

Locations (4)

Allina Health Systems; 🇺🇸 Edina, Minnesota, United States

Hawkins Foundation; 🇺🇸 Greenville, South Carolina, United States

Appalachian Orthopedic Associates; 🇺🇸 Johnson City, Tennessee, United States

ROC Foundation; 🇺🇸 Reno, Nevada, United States